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Use of Total-Body PET to Quantify Systemic and Cutaneous Inflammation in Psoriasis Patients Before and After Intervention With a Nutritionally Balanced Diet

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This inflammation of the skin, joints, and blood vessels in patients with psoriasis has been measured by older PET Scan technology but with limitations."
  • "Thus, this study aims to assess whether there are detectable decreases in inflammation of the skin and body of psoriasis patients who usually eat a Western Diet on an EXPLORER PET scan following 6 weeks of a more balanced diet."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the EXPLORER total-body PET scanner can measure inflammation better than older PET scanners. It also tests whether a balanced diet for 6 weeks lowers inflammation in the skin and body. It is for adults with psoriasis who are overweight and usually eat a Western-style diet.

Psoriasis is a chronic inflammatory disease that affects the skin and joints in 2-3 % of people in the United States. This inflammation of the skin, joints, and blood vessels in patients with psoriasis has been measured by older PET Scan technology but with limitations. With the new EXPLORER PET scanner technology, the investigators are testing to see if the EXPLORER is better than previous PET scanners and improve our ability to assess inflammation in patients. Also, it is known that the typical Western Diet - high in saturated fats, added sugars, and low in fiber - contributes to obesity and inflammation worldwide. There is evidence in animals that these signs of inflammation are reversible within 4 weeks when changed to a more balanced diet. Thus, this study aims to assess whether there are detectable decreases in inflammation of the skin and body of psoriasis patients who usually eat a Western Diet on an EXPLORER PET scan following 6 weeks of a more balanced diet.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18. People of any sex may join.
  • Have a history of psoriasis affecting at least 3% of your skin. Skin biopsies, which remove small skin samples, are optional.
  • You may also have psoriatic arthritis, which causes joint swelling and pain.
  • Have a body mass index (BMI) of 25 or higher, which is in the overweight range or above.
  • Be willing and able to go without food for at least 6 hours before the scan and throughout the scan visit.
  • Avoid hard exercise for 24 hours before the scan.
  • Usually eat a Western-style diet, high in saturated fat and added sugar and low in fiber. Food surveys and records must show a Healthy Eating Index score below 58.

Who can't join

  • Take diabetes pills or injections; have uncontrolled diabetes; or have blood sugar above 180 mg/dL when the scan tracer is injected.
  • Already limit calories or parts of your diet; follow a vegan or vegetarian diet; or have an allergy or intolerance to foods in the study diet.
  • Have had a body weight change of more than 5% in the past 2 months, or weigh more than 240 kg (about 529 pounds).
  • Take medicines that work throughout the body to treat psoriasis or psoriatic arthritis during the study or for at least 3 months before the first PET scan.
  • Have distress or anxiety in closed spaces, or cannot lie still with your arms at your sides for up to 60 minutes.
  • Have another illness causing inflammation or an infection that could affect the results; or are pregnant or breastfeeding.
  • Are in another study that conflicts with this one, or have had a PET scan only for research within the past 12 months.
  • Are unwilling to sign the consent form, cannot understand the study's risks and benefits, or are a prisoner.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Adults (\>18 year) * Both sexes * Must have a history of psoriasis of at least 3% body surface area affected by skin psoriasis (in a body area that the subject will allow the PI to perform several skin biopsies as noted below (optional)) and may carry a diagnosis of psoriatic arthritis as well * Patients will have a BMI of \>/=25 which is consistent with being overweight - Willing and able to fast for at least 6 hours before and for the duration of the scan visit * No strenuous exercise for 24 hours prior to being scanned * Recruited patients must habitually consume a WD-type diet that will be evaluated by using DHQ III food frequency questionnaire along with three-day food record14. Subsequently, the Healthy Eating Index will be calculated and participants with a poor dietary pattern (score below 58) will be eligible for the study15. Exclusion Criteria: * Those taking anti-diabetic oral or injected medications * Those already ingesting a caloric- or component-restricted diet * Vegan, vegetarian or food allergy or intolerance to the ingredients of the diet * \>5% change in body weight in the last 2 months * Those taking systemic medications for the purpose of treating psoriasis or psoriatic arthritis for at least 3 months prior to first PET scan or during the duration of the trial * Self-reported history of dysphoria or anxiety in closed spaces (claustrophobia) * Uncontrolled diabetes or blood glucose level greater than 180 mg/dl at the time of radiotracer injection * Body weight \>240 kg due to limitations of the scanner bed * Known inflammatory or other infectious disease that can confound assessment * Pregnant or breast-feeding (urine pregnancy test will be administered prior to start of each PET/CT session for all participants who are able to get pregnant between 18 to 60 years old, unless documented hysterectomy or bilateral ovarian removal is available, because of risks from ionizing radiation) * Inability to lie motionless on the scanner bed with the arms by the side for up to 60 minutes * Currently participating in another conflicting research study. Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only. * Unwilling to sign informed consent * Inability to understand the risks and benefits of the study * Prisoners

Study sites (1)

CA